Packing device for endoscopic procedures

ABSTRACT

A packing device for use in endoscopic operative procedures is formed of an elongate strip of absorbent, preferably expandable material having a rigid, dry state of a size to permit passage through a narrow endoscopic portal to an internal operative site and having a soft wet state when body fluids are absorbed thereby such that the packing device exposes and isolates tissue to be treated and protects adjacent tissue at the operative site while, in the dry state, is sufficiently rigid to manipulate tissue. A method of packing an internal operative site during an endoscopically performed procedures includes inserting a rigid strip of absorbent, preferably expandable, material through a narrow endoscopic portal and positioning the strip of material at the operative site such that at least a portion of the strip of material absorbs body fluids to become soft and pliable.

This application is a continuation of application Ser. No. 07/789,599,filed Nov. 8, 1991, now abandoned, which is a division of applicationSer. No. 07/556,081, filed Jul. 24, 1990, now U.S. Pat. No. 5,074,840.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to medical packing and, moreparticularly, to packing devices and methods for endoscopicallyperformed operative procedures.

2. Discussion of the Prior Art

Endoscopically performed operative procedures are preferred for surgeryon the human body due to their least invasive nature and reduced traumaand tissue damage as compared with open surgery. There are many commonendoscopically performed operative procedures including, for example,laparoscopy (pelviscopy), gastroentroscopy, laryngobronchoscopy andarthroscopy. While endoscopically performed operative procedures arepreferred, there are obstacles to expanding endoscopy to include thevarious procedures currently performed with open surgery. One of theobstacles is that packing of the internal operative site has not beenable to be accomplished in the past due to the fact that access to theoperative site is available only through a narrow portal normallyincluding a cylindrical sleeve positioned by means of a puncturinginstrument. Without packing, endoscopic procedures are much moredifficult and dangerous to perform, even with the use of instrumentsparticularly useful in endoscopy, such as laser and electrosurgicalinstruments, since the tissue or organ structure cannot be adequatelyexposed and manipulated, the surrounding tissue and organ structure isnot protected during the procedure and body fluids cannot be removedfrom the operative site without the use of expensive and cumbersomesuction equipment.

There is a great need to expand the types of procedures that can beendoscopically performed in order to decrease trauma and recovery timefor patients while simultaneously reducing medical costs. Accordingly,much effort has been expended in the development of endoscopicinstruments for specific procedures; however, to date, no adequatesystem has been devised to permit packing during endoscopicallyperformed operative procedures.

SUMMARY OF THE INVENTION

Accordingly, it is a primary object of the present invention to providea packing device for use in endoscopically performed operativeprocedures to expand the types of procedures that can be performedendoscopically while increasing patient safety and exposure of operativesites in endoscopic procedures presently being performed.

Another object of the present invention is to form a packing device ofan elongate strip of absorbable material having a rigid dry stateallowing passage through a narrow endoscopic portal and permittingtissue manipulation and precise positioning at an internal operativesite to expose tissue and organ structures to be treated, absorb bodyfluids and protect adjacent tissue and organ structures.

A further object of the present invention is to pack an internaloperative site through a narrow endoscopic portal using a strip ofabsorbent material having a rigid, dry state prior to use and a softflexible, wet state when exposed to body fluids.

Yet an additional object of the present invention is to endoscopicallypack an internal operative site using a strip of absorbent materialhaving a relatively straight configuration in a dry state and assuming adifferent, non-straight configuration in a wet state to allow the stripof material to have a predetermined configuration when positioned at theoperative site to absorb body fluids.

Some of the advantages of the present invention over the prior art arethat precise packing at an internal operative site is accomplished via anarrow portal thereby expanding the types of procedures that can beperformed endoscopically and, further, increasing safety and efficacy inendoscopic procedures in general, that the packing device is rigid orstiff in a dry state to allow precise placement thereof as well asmanipulation of tissue, that the packing device facilitates removal ofinfected fluids, such as pus, and abnormal fluids, such as cysticfluids, that the packing device serves as a culturing medium to identifyspecific infected organisms, that the packing device can applymedicaments to tissue, and that, when a plurality of packing devices areused in an endoscopic procedure, each packing device is individuallyidentified externally to facilitate manipulation.

The present invention is generally characterized in a packing deviceformed of an elongate strip of absorbent, preferably expandable,material having a rigid dry state of a size to permit passage through anarrow endoscopic portal to an internal operative site and having asoft, flexible or rigid, wet state when body fluids are absorbedthereby. A method of packing an internal operative site during anendoscopically performed procedure includes inserting a rigid strip ofabsorbent, preferably expandable, material through a narrow endoscbpicportal and positioning the strip of material at the operative site suchthat at least a portion of the strip of material absorbs body fluids tosoften the material.

Other objects and advantages of the present invention will becomeapparent from the following description of the preferred embodimentstaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a packing device in combination with atrocar sleeve in accordance with the present invention.

FIG. 2 is a top plan view of a packing device in accordance with thepresent invention in a dry state.

FIG. 3 is a top plan view of the packing device of FIG. 2 in anexpanded, wet state.

FIGS. 3A and 3B are broken views of the packing device in variousconfigurations in the wet state.

FIG. 4 is a broken view showing a method of endoscopic packing accordingto the present invention.

FIGS. 5 and 6 are plan views, partly broken away, of other embodimentsof packing devices according to the present invention.

FIG. 7 is a broken view of a further embodiment of a packing deviceaccording to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

A packing device in combination with a trocar or portal sleeve inaccordance with the present invention is shown in FIG. 1. The trocarsleeve 10 has a distal end for being disposed within the body, aproximal end for being disposed externally of the body and a lumenbetween the distal and proximal sleeve ends for receiving instruments.The proximal end terminates at a hub 12 having a valve 14 thereinforming a passage that can be opened to permit instruments to passthrough sleeve 10. The trocar sleeve, hub and valve form a conventionaltrocar assembly commonly used in laparoscopy wherein a trocar, notshown, passes through sleeve 10 and is used to puncture apneumoperitoneum and is thereafter withdrawn leaving the sleeve in placewith the distal end thereof disposed within the body to form a portal togain access to an internal operative site. The valve minimizes loss ofinflating fluid. The packing device 16 of the present invention can beused with any type of endoscopic portal providing access to an internaloperative site, with or without a sleeve or cannula; and, the trocarsleeve 10 is exemplary only.

The packing device 16 is formed of an elongate strip of absorbent,preferably expandable, material 18, as shown in FIG. 2, in a rod-like,relatively straight configuration, attached at a proximal end to astrong, flexible string 20 having an identification tag 22 at its end.The material 18 can be any type of medical grade absorbent material thatcan absorb body fluids and, preferably, expand from two to four timesits size in a dry state prior to abosorbing body fluids, and that isrelatively rigid or stiff in the dry state. While an expandable materialis preferred to facilitate packing and tissue exposure, if desired, theabsorbent material can be non-expandable as long as the material becomessoft and pliant in the wet state after absorption of body fluids. Spongematerials have been found to be the most effective for the packingdevice, for example, the sponge material utilized in Lamicel osmoticcervical dilators manufactured by Cabot Medical Corporation. In the drystate, the packing device must be sufficiently rigid to allow thepacking device to be manipulated in a fashion to be positioned adjacentan operative site to expose and isolate tissue or organ structure to betreated, the rigid nature of the packing device 16 also allowing thepacking device to be used to contact and move or position tissue andorgan structures to facilitate the procedure to be endoscopicallyperformed. In the dry state, the packing device is essentially a spongestick. The length and width or lateral size of the packing device willdepend upon the procedure to be endoscopically performed; and, as shownin FIG. 1, the packing device has a length longer than the length of thetrocar sleeve and hub.

Once the packing device comes into contact with body fluids, thematerial 18 will absorb the fluids and expand to a wet state as shown inFIG. 3. In the wet state, the material is soft and flexible facilitatinguse of the swollen packing device at the operative site.

The construction of the packing device is dependent upon the type ofabsorbent material employed and the procedure to be performed includingthe force required to remove the packing device after the procedure iscompleted. To this end, the string 20 can be suitably attached to theproximal end of the elongate strip of material 18 or the string can passcentrally through the material 18, as shown at 20', to form a core-likesupport attached to the material along the length thereof. The stringshould have sufficient tensile strength to prevent breakage of thestring when the packing is pulled from the body by grasping the stringor tag 22. When the core-like support 20' passes through the material,it can be radiopaque to enhance visualization thereof. The tags 22 canalso be radiopaque and, preferably, carry indicia for identifying ordistinguishing each packing device, the indicia taking the form ofdifferent colors and/or alpha-numeric labeling.

The core-like support 20' can be formed of any suitable material such asstring, plastic or metal. In accordance with a particularly advantageousembodiment of the, present invention, the core-like support 20' hasresilient, spring-like properties and has a normal configurationdesigned for a particular operative procedure. For example, thecore-like support 20' can have the shapes shown in FIGS. 3A or 3B in thenormal state. To this end, the core-like support can be made of springmetal to have a curved configuration; and, when the packing device ismanufactured, the core-like support is straightened and the absorbentmaterial 18 is attached to the core-like support, for example withadhesive, such that the dry, stiff condition of material 18 maintainsthe core-like support in a relatively straight configuration.Accordingly, the packing device 16 can be easily inserted through sleeve10; and, once the packing device is in the body, material 18 will absorbbody fluids to become soft and allow the core-like support 20' to returnto its normal configuration producing a packing device of predeterminedconfiguration for use in specific procedures. The shape memory of thecore-like support can be accomplished in any suitable manner, andsupport 20' can be disposed within material 18 or externally along anouter edge of material 18.

In use, after the trocar is withdrawn, the sleeve 10 will provide aportal extending through the skin 23 and the fascia, muscle and anteriorperitoneum as shown generally at 24 in FIG. 4. With the sleeve in place,a packing device 16 is passed through the sleeve; and, due to theinitial rigidity of the material 18, the packing device can be moved tomanipulate tissue to be positioned at the internal operative site toexpose the tissue to be treated. As shown in FIG. 4, the packing device16 is positioned to isolate and expose an appendix 26 to facilitatetreatment, such as surgical removal, thereof while protectingsurrounding tissue and organ structures, such as the mesentery 27 or thebowel, not shown. Of course, more than one packing device will be usedfor most procedures, and each packing device will be insertedsuccessively through sleeve 10, or a plurality of sleeves 10, in themanner described above and positioned at the operative site. Since thetag attached to each packing device carries different indicia, specificpacking devices can easily be externally, identified. Once the procedureis completed, for example with the use of laser, electrosurgical ormechanical instruments, the sleeve 10 is withdrawn. A single packingdevice can be withdrawn with the sleeve, and additional packing devicescan be withdrawn singly or in pairs dependent upon their expanded,swollen size.

The packing device, along with being effective to absorb body fluids,move or manipulate tissue, expose and isolate tissue to be treated andprotect tissue adjacent an operative site, can also be used to collecttissue or fluid for sampling or culture by contacting the tissue orfluid to be sampled with a portion of the packing device in the drystate and then withdrawing the packing device. The dry, medical gradesponge material 18 can be medicated, biodegradable, non-biodegradable,radiopaque and/or culturable for organisms.

Other embodiments of packing devices according to the present inventionare shown in FIGS. 5 and 6. In the embodiment of FIG. 5, a strip ofmaterial 18', such as compacted gauze sponge, is disposed in aserpentine or corrugated configuration within a rigid delivery tube 28,and a rod 30 is attached to the proximal end of the material tofacilitate deployment and manipulation of the strip of material at theoperative site. In the embodiment of FIG. 6, a strip of material 18" isrod shaped, and a rod 30 is attached to the proximal end of thematerial, the rod 30 and material 18" being disposed within a rigiddelivery tube 28 in the same manner as in the embodiment of FIG. 5.

The endoscopic packing system of the present invention as describedabove permits the expansion of endoscopic procedures to many areas thatwere previously difficult to reach and visualize and/or dangerous to thepatient. For example, the manipulation of the packing device 16 in thedry, stick-like, state acts like a probe allowing the surgeon to see andexpose the gall bladder during an endoscopic procedure. The diameter ofthe packing device will vary in accordance with the procedure to beperformed and the size of the portal; and, typically, the packingdevices will have diameters of 3 mm, 5 mm, 8 mm and 10 mm. To enhanceviewing of the packing device in the body, the material 18 is preferablywhite in color to provide contrast with the surrounding tissue. Sincethe packing device is rigid in the dry state, tissue manipulation isenhanced in that initial absorption, softening and expansion occurs onlyat the portion contacting wet organ structure. Thus, even though thepacking device will normally absorb body fluids and soften and expandwithin a minute of contact, the packing device is particularly effectivein exposing and isolating tissue to be treated, and manipulating andprotecting tissue.

A further embodiment of a packing device 16' according to the presentinvention is shown in FIG. 7 in a wet state. The primary differencebetween packing device 16' and the previously described packing devicesis that the string 20a and the core-like support 20'a are hollow ortubular as is the tag 22a core-like support 20'a has perforations 32therein. The tag 22a has an inlet 34 communicating with hollow string20a and an outlet 36 adapted to be connected with a source of suctionand/or a drainage collection reservoir. The perforations 32 allowselective or continuous drainage of body fluids through core-likesupport 20'a and string/tube 20a and tag 22a when the packing device iswet.

Inasmuch as the present invention is subject to many modifications,variations and changes in detail, it is intended that all subject matterdiscussed above or shown in the illustrative drawings be interpreted asillustrative only and not to be taken in a limiting sense.

What is claimed is:
 1. In combination, a portal sleeve and a packingdevice for packing an internal operative site within the body of apatient in an endoscopically performed operative procedure where anarrow portal provides access to the operative site, the combinationcomprisingan elongate structural portal sleeve for establishingcommunication with the operative site from externally of the body whensaid portal sleeve is disposed in the narrow portal, said portal sleevehaving a distal end for being disposed within the body, a proximal endfor being disposed externally of the body and a lumen between saiddistal and proximal ends; and a packing device comprising a deliverytube for being received in said lumen, an elongate strip of absorbentmaterial capable of absorbing fluid, said strip of material having a drystate prior to absorbing fluid and a wet state when fluid is absorbed bysaid strip of material, said strip of material being rigid and stiff insaid dry state and being soft and flexible in said wet state, said stripof material being disposed in said delivery tube in said dry state, anda rod attached to said strip of material and extending externally of thebody when said delivery tube is received in said lumen, said rod beingmovable distally and proximally relative to said portal sleeve whileremaining attached to said strip of material to force said strip ofmaterial from said tube and said portal sleeve to introduce said stripof material at the operative site and to manipulate said strip ofmaterial at the operative site once said strip of material has beenforced from said portal sleeve.
 2. The combination device as recited inclaim 1 wherein said strip of material has a rod-shaped configuration insaid dry state.
 3. The combination as recited in claim 1 wherein saidstrip of material has a corrugated configuration in said dry state. 4.The combination as recited in claim 1 wherein said strip of materialexpands when fluid is absorbed thereby.
 5. The combinaiton as recited inclaim 1 wherein said strip of material has a proximal end and said rodincludes a portion passing centrally through said strip of material anda portion extending from said proximal end of said strip of material tobe disposed externally of the body when said delivery tube is receivedin said lumen.
 6. In combination, a portal sleeve and a packing devicefor packing an internal operative site within the body of a patient inan endoscopically performed operative procedure where a narrow portalprovides access to the operative site, the combination comprisinganelongate structural portal sleeve for establishing communication withthe operative site from externally of the body when said portal sleeveis disposed in the narrow portal, said portal sleeve having a distal endfor being disposed within the body, a proximal end for being disposedexternally of the body and a lumen between said distal and proximalends; and a packing device comprising a delivery tube for being receivedin said lumen, an elongate strip of absorbent material capable ofabsorbing fluid, said strip of material having a dry state prior toabsorbing fluid and a wet state when fluid is absorbed by said strip ofmaterial, said strip of material being rigid and stiff in said dry stateand being soft and flexible in said wet state, said strip of materialbeing disposed in said delivery tube in said dry state, a rod attachedto said strip of material and extending externally of the body when saiddelivery tube is received in said lumen, said rod being movable distallyand proximally relative to said portal sleeve while remaining attachedto said strip of material to force said strip of material from said tubeand said portal sleeve to introduce said strip of material at theoperative site and to manipulate said strip of material at the operativesite once said strip of material has been forced from said portal sleeveand means for constraining said strip of material to assume apredetermined configuration in said wet state upon absorption of fluidby said strip of material after introduction of said strip of materialat the operative site.
 7. A packing device for packing an internaloperative site in an endoscopically performed operative procedure whereone or more narrow portals provide access to an operative site in thebody, said packing device comprising a plurality of elongate strips ofabsorbent material capable of absorbing body fluids, said strips ofmaterial each having a dry state prior to absorbing body fluids and asoft, flexible, expanded wet state when body fluids are absorbed by saidstrips of material, said strips of material each having a lateral crosssectional size in said dry state to permit passage of said strips ofmaterial through the one or more narrow portals and each having a lengthto permit positioning of said strips of material at the operative site,and indicia carried by each of said strips of material for beingdisposed externally of the body for distinguishing said strips ofmaterial from one another externally of the body.
 8. A packing device asrecited in claim 7 wherein said indicia includes a plurality of stringseach having a first end and a second end, each of said strips ofmaterial having one of said first ends attached thereto, each of saidsecond ends having a color different from the color of the other secondends to distinguish said strips of material from one another.
 9. Incombination, a portal sleeve and a packing device for packing aninternal operative site within the body of a patient in anendoscopically performed operative procedure where a narrow portalprovides access to the operative site, the combination comprisinganelongate structural portal sleeve for establishing communication withthe operative site from externally of the body when said portal sleeveis disposed in the narrow portal, said portal sleeve having a distal endfor being disposed within the body, a proximal end for being disposedexternally of the body and a lumen between said distal and proximalends; and a packing device comprising a delivery tube for being receivedin said lumen, an elongate strip of absorbent material capable ofabsorbing fluid, said strip of material having a proximal end, saidstrip of material having a dry state prior to absorbing fluid and a wetstate when fluid is absorbed by said strip of material, said strip ofmaterial being rigid and stiff in said dry state and being soft andflexible in said wet state, said strip of material being disposed insaid delivery tube in said dry state, a rod attached to said strip ofmaterial and extending externally of the body when said delivery tube isreceived in said lumen, said rod being movable distally and proximallyrelative to said portal sleeve while remaining attached to said strip ofmaterial to force said strip of material from said tube and said portalsleeve to introduce said strip of material at the operative site and tomanipulate said strip of material at the operative site once said stripof material has been forced from said portal sleeve, said rod includinga portion passing centrally through said strip of material and a portionextending from said proximal end of said strip of material to bedisposed externally of the body when said delivery tube is received insaid lumen, said rod being tubular and defining hollow drainage meanscoupled with said strip of material for collecting and removing fluidsfrom the operative site.
 10. A packing device for packing an internaloperative site for an endoscopically performed operative procedure wherea narrow portal is established to provide access to the operative site,said packing device comprising an elongate strip of absorbent materialcapable of absorbing body fluids, said strip of material having a rigiddry state prior to absorbing body fluids and a soft, flexible wet statewhen body fluids are absorbed by said strip of material, said strip ofmaterial having a lateral cross sectional size in said dry state topermit passage of said strip of material through the narrow portal andhaving a length to permit positioning of said strip of material at theoperative site, and a support attached to said strip of material andhaving a normally non-straight predetermined configuration prior tobeing attached to said strip of material, said support, when attached tosaid strip of material, being maintained by said absorbent material in arelatively straight configuration when said strip of material is in saiddry state and returning to said non-straight configuration when saidstrip of material is in said wet state.
 11. A packing device as recitedin claim 10 wherein said support includes a spring.
 12. A packing deviceas recited in claim 10 wherein said support has shape memory causingsaid support to return to said non-straight configuration when saidstrip of material is in said wet state.
 13. A packing device as recitedin claim 10 wherein said strip of material includes a proximal end andsaid support includes a hollow member having a portion passing centrallythrough said strip of material and a portion extending from saidproximal end, said portion of said member passing through said strip ofmaterial having perforations therein to collect and drain body fluids.